Today’s Flickr Photo

The U.S. Supreme Court for Sale. Flickr photo by takomabibelot.

If you read one thing today . . .

We already knew that pharma giant GlaxoSmithKline wasn’t above putting profits before patient health. There’s the case of its diabetes drug Avandia, the sale of which the FDA recently restricted. And now comes the disturbing news that the British drug maker knowingly sold contaminated baby ointment and an antidepressant that didn’t work. Glaxo will pay $750 million to settle criminal and civil complaints in this latest round of court cases, write Gardiner Harris and Duff Wilson in the New York Times. The case was sparked by complaints from Glaxo’s former quality manager, Cheryl D. Eckard, who told the FDA about serious problems at Glaxo’s premier manufacturing facility in Puerto Rico:

But Ms. Eckard soon discovered that quality control was a mess: the water system was contaminated; the air system allowed for cross-contamination between products; the warehouse was so overcrowded that rented vans were used for storage; the plant could not ensure the sterility of intravenous drugs for cancer; and pills of differing strengths were sometimes mixed in the same bottles.

Although F.D.A. inspectors had spotted some problems, most were missed. And the company abandoned even the limited fixes it promised to conduct, the unsealed lawsuit says. Ms. Eckard complained repeatedly to senior managers; little was done. She recommended recalls of defective products; recalls were not authorized. In May 2003, she was terminated as a “redundancy.”

Overheard:

By now you’ve probably seen the video from the Rand Paul for U.S. Senate campaign rally in Lexington, Ky. where Paul supporters wrestled a female MoveOn.org protestor to the ground and one man stepped on her head. The guy who appears on video to be stomping 23-year-old Lauren Valle has told reporters that he wasn’t trying to hurt her. Rather, he was trying to hold her down for police and had to use his foot because a bad back prevents him from bending over. Valle told police she was assaulted while trying to take a photo with Paul while holding a fake “employee of the month” award:

“I think that this is an extreme example of the kinds of sentiments that people are feeling in many races across the country,” Valle said. “I think that tension is incredibly high.”

During that time, my colleagues and I combed through over 250,000 pages of internal GSK documents and interviewed dozens of witnesses and whistleblowers. What emerged was a troubling picture of a company that had placed corporate profits over patient safety. While suppressing inconvenient evidence about the risks of its top-selling drug, the company even began to develop another drug to treat the very side effect Avandia has been linked to.

Yes, you read that right — Instead of recalling Avandia, which was linked to causing heart attacks in patients, GlaxoSmithKline decided the better thing to do was to develop another drug that could treat the condition caused by Avandia.

By failing to ban the dangerous diabetes drug, Avandia, generic name rosiglitazone, the Food and Drug Administration (FDA) again caved to industry pressure. Although the FDA has made progress highlighting the risks of using Avandia by severely restricting the drug, it did not go far enough. Too many people could still be exposed to this dangerous product. Rather, the FDA should have acted with its European counterpart and outright banned Avandia from the market.

Why did it take the FDA so long to decide that a drug with no evidence of any advantage in health benefits, but abundant evidence of a variety of risks compared to other diabetes drugs, should be severely restricted? Why did it not ban this unsafe product?

More than three years ago at an FDA advisory committee meeting, Public Citizen urged the FDA to ban Avandia. Since then, 9 million prescriptions for the drug have been filled in the United States. This means that, just in the past three years alone, tens of thousands more patients have needlessly suffered hospitalizations for heart failure or deaths than would have had they taken Actos, a comparable, but safer drug.

There is not a single study finding that Avandia is safer than Actos, but there are numerous studies finding that Avandia is more dangerous than Actos. The FDA and GlaxoSmithKline have acted recklessly in allowing Avandia to stay on the market for so long after its unique dangers have been known.

The FDA should reconsider its decision to merely restrict such a hazardous product and directly remove it from the market.

Tomorrow, our own Sid Wolfe will be testifying before an FDA advisory committee about the much talked about diabetes drug Avandia, manufactured by drug maker GlaxoSmithKline. The New York Times reported today that GlaxoSmithKline hid data indicating Avandia’s adverse effects for 11 years. The New York Times also explained the history of this dangerous drug.

In the fall of 1999, the drug giant SmithKline Beecham secretly began a study to find out if its diabetes medicine, Avandia, was safer for the heart than a competing pill, Actos, made by Takeda.

Avandia’s success was crucial to SmithKline, whose labs were otherwise all but barren of new products. But the study’s results, completed that same year, were disastrous. Not only was Avandia no better than Actos, but the study also provided clear signs that it was riskier to the heart.

But instead of publishing the results, the company spent the next 11 years trying to cover them up, according to documents recently obtained by The New York Times. The company did not post the results on its Web site or submit them to federal drug regulators, as is required in most cases by law.

Excuse our impatience, but we’ve been warning about Avandia for a decade. We petitioned the Food and Drug Administration to ban Avandia (also known as Rosiglitazone) back in 2000. Sid Wolfe has been saying all the things “recently uncovered” for years. It finally looks like something might happen though; the FDA is meeting to discuss Avandia today.

One analysis, involving more than 35,500 people, found that Avandia significantly raises the chances of a heart attack. The second, a federal analysis of more than 227,500 Medicare patients — the largest such study to date — found that the drug boosts the risk for strokes, heart failure and death.

However the new research still has not stopped drug maker GlaxoSmithKline from claiming that its drug is safe. Yet earlier this week a Senate investigation concluded GlaxoSmithKline has known about the possible risks from Avandia – yet they never filed it with the FDA.

Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, said allowing Avandia to remain on the market runs counter to what top FDA officials have said about putting the public’s health first.

Every month that the FDA fails to get the drug withdrawn from the market means that an additional 150,000 to 200,000 prescriptions will be filled in this country, needlessly exposing people to the increased risk of stroke, heart failure and heart attacks.

An unpublished FDA study indicated that 48,000 heart attacks, strokes and other cardiovascular problems in the elderly between 1999 and 2009 could have been prevented if the patients had taken other medications instead of the controversial diabetes drug Avandia.

As government officials try to get to the bottom of who is to blame for the massive BP oil spill, Public Citizen has been featured in top media coverage of the catastrophe. Tyson Slocum, Public Citizen’s Energy Program director, has become a go-to guy on the issue, being interviewed on radio and television networks across the country. Slocum was featured on Bloomberg TV’s “Inside Track,” SiriusXM/POTUS radio talking about the government’s reaction to the spill and CBS Radio’s “The John Carney” show about BP’s history of safety records. He noted that BP has “one of the worst safety records of any oil company operating in America.”

Slocum made headlines in Canada and Cuba, as well. Slocum has been featured in a variety of articles from coast to coast including The New York Times and Los Angeles Times. Public Citizen also has been quoted on the issue by Reuters, Albany Times Union, Politico, The Washington Independent, The NACS, “The People’s Voice,” 2TheAdvocate.com and The Palestine Telegraph.

Also making headlines is Public Citizen calling on the Food and Drug Administration to stop the risky trail of GlaxoSmithKline’s diabetes drug, Avandia. The drug is believed to put patients at risk for heart attack and chest pain.

The Avandia trial is “exposing thousands of high-risk patients with diabetes to a drug with an unfavorable safety profile and no clinical advantage over its comparator.”

Public Citizen’s efforts to stop the trial have gained international attention. Sidney Wolfe was quoted on CBC across Canada as well as in a Metro Canada Toronto story on the trial. The story gained attention in parts of Europe and was featured on Pharmacy Europe, a website for European hospitals and clinical pharmacists. Back in the States, Public Citizen was quoted in the Los Angeles Times, Post Chronicle, National Post, Business Spectator, and msnbc.com.

Public Citizen has also made headlines with many other issues including, the climate bill, Capitol Hill’s limits on lobbying and Florida’s doctor discipline system. Keep checking back for more!

“A wealth of data now suggests” that Avandia carries greater risks than Actos, the researchers said. Patients are also not adequately informed about the safety differences between the two medicines when deciding whether to participate in the trial, they added.

But FDA officials, who have said they are already taking a closer look at Avandia, are not likely to act so quickly.

In act, both drugs [Avandia and Actos] have been tagged with safety issues: In addition to raising rates of cardiovascular events, the class of Type 2 diabetes drugs known as thiazolidinediones (or TZDs) have been linked in studies to higher rates of edema, macular edema, bony fractures, anemia and acute liver injury. Older diabetes medicine such as metformin and sulfonylurea are widely believed to be safer alternatives.